Summary
Overview
Work History
Education
Skills
Project Details
Timeline
Generic

DEEBIKA A

Chennai

Summary

Experienced bench chemist turned regulatory affairs executive with a strong foundation in laboratory practices and regulatory compliance, seeking to leverage my expertise in regulatory submissions, risk assessment, and cross-functional collaboration in a regulatory affairs role. I aim to contribute to the successful approval and commercialization of products by ensuring compliance with industry regulations and fostering effective communication with regulatory authorities. I am dedicated to staying informed on evolving regulatory landscapes and am eager to support product development with my analytical skills and attention to detail.

Overview

3
3
years of professional experience

Work History

Regulatory Affairs Executive

Axxelent Pharma Science Private Limited
04.2022 - 11.2022
  • As a regulatory executive, review and authorization of all technical documents such as API/Finished Product/ Excipients were performed.
  • Responsible for review of RLD package insert for generic drug development.
  • Handling Licensing activities such as NOC, Test License, Import License and responsible for submission of responses to queries.
  • Training in ICH Guidelines of safety, Quality, Efficacy and Multidisciplinary.
  • The application process handled : NOC, test license and import license for generic products.
  • Reviewing the package inserts of RLD and reference substances.
  • Coordinate activities among team members to meet project milestones and deadlines.

Bench Chemist

Central Drugs Testing Laboratory
06.2019 - 03.2022
  • As a Bench Chemist, I did Quantitative and Qualitative estimation on pharmaceutical finished products, active pharmaceutical ingredients and cosmetics.
  • Instruments handled such as UV visible spectrometer, FTIR, High performance liquid chromatography, dissolution apparatus, disintegration test apparatus, and digital polarimeter.
  • Record experimental data meticulously and maintain accurate laboratory notebooks.
  • Manage laboratory supplies and chemicals, ensuring adequate inventory levels and proper storage.

Education

M.Pharm -

Madurai Medical College
Madurai, India
04.2001 -

B.Pharm -

Madras Medical College
Chennai, India
04.2001 -

12th - Biology And Mathematics

M.Ct.M Girls Higher Secondary School
Purasaiwakam, Chennai
04.2001 -

Skills

Certification - Pharma drug regulatory affairs certificate course - DRA 2024 (Udemy)

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Project Details

  • B. Pharmacy : Synthesis and characterization of antimicrobial activity of some indole derivatives.
  • M. Pharmacy : Pharmacognostical, phytochemical studies and evaluation of anti-thyroid activity on leaves of Cichorium intybus L. (Asteraceae).

Timeline

Regulatory Affairs Executive

Axxelent Pharma Science Private Limited
04.2022 - 11.2022

Bench Chemist

Central Drugs Testing Laboratory
06.2019 - 03.2022

M.Pharm -

Madurai Medical College
04.2001 -

B.Pharm -

Madras Medical College
04.2001 -

12th - Biology And Mathematics

M.Ct.M Girls Higher Secondary School
04.2001 -

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